Method of making polymeric gloves having embedded surgical support systems and discrete elements

ABSTRACT

A method of manufacturing a glove that includes discrete elements and component systems, such as, but not limited to, lights, electrical cautery, suction, and irrigation, attached to the surgical glove. The gloves produced by this method can be used as surgical gloves or for other industrial applications. In a particular application, the method includes providing a former comprising a hand-shaped portion and a first surgical system comprising a first surgical instrument, and a first switch for controlling the first surgical system. The former includes a first depression for receiving the first surgical system. The first depression is adapted to produce an interference fit with at least a portion of the first surgical system. The first surgical system can be loaded into the first depression and a polymer coating can be applied over the loaded former to form a surgical glove.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application claims priority to U.S. Provisional Patent ApplicationNo. 61/539,350, entitled “Surgical Glove Systems and Methods of Makingthe Same,” filed Sep. 26, 2011, the entirety of which is incorporatedherein by reference.

FIELD OF THE INVENTION

This invention is directed generally to a method of manufacturingsurgical gloves including integral surgical systems for use by a surgeonduring surgery.

BACKGROUND

U.S. Pat. Nos. 7,931,648, 7,951,145 and 8,182,479 to Schneider(“Schneider Patents”) disclosed surgical systems that include a glovewith multiple surgical support systems attached thereto. Such glovesprovide a number of advantages over conventional surgical systems wherethe gloves and surgical support systems (e.g., electrocautery, suction,irrigation, light, etc.) are not integrated. There are a wide variety oftechniques useful for manufacturing conventional surgical gloves, whichallow for high volume production of surgical gloves that meet stringentregulatory standards. However, these techniques are not sufficient formanufacturing the multi-functional surgical gloves described in theSchneider Patents, as they do not allow for the integral inclusion ofembedded surgical support systems or other elements at the time of gloveformation. Adapting commercial products to include surgical supportsystems would require post-formation processes that would not be costeffective and could compromise the gloves barrier properties. Therefore,there is a need for improvement in the techniques available in order tomake and manufacture the surgical systems described in the SchneiderPatents in a consistent, commercially reliable and cost-effective mannerthat will not compromise the surgical glove's material integrity orability its to meet the required regulatory standards.

SUMMARY OF THE INVENTION

This invention relates to a method of making polymeric gloves, includingsurgical gloves or other industrial gloves, that contain embeddedfunctional components. The method of making can include providing afirst functional component, wherein the first functional component isselected from a first discrete element and a first component systemcoupled to a first conduit. The method can the include providing aformer comprising an appendage-shaped portion, where the former includesa first depression for receiving the first functional component. Themethod can include loading the first functional component into the firstdepression; and applying a polymer coating over the loaded former toform an polymeric glove.

The first depression can be adapted to produce an interference fit withat least a portion of the first functional component. A portion of thefirst functional component can be embedded within the polymeric gloveand another portion of the first functional component can be exposed.

The first functional component can be a first component systemcomprising a first active end and a first conduit, and the firstdepression can include a corresponding first active end receivingportion and a first conduit receiving portion. The loading step caninclude loading the first active end into the first active end receivingportion and the first conduit into the first conduit receiving portion.Exemplary active ends include light sources, cutting tips, suction tips,and irrigation tips. The first functional component is a first discreteelement.

The method can also include providing a second functional component,where the second functional component is selected from a second discreteelement and a second component system coupled to a second conduit. Theformer can also include a second depression for receiving the secondfunctional component, and the method can include loading the secondfunctional component into the second depression.

In a specific application, the method can include providing a firstsurgical system comprising a first surgical instrument and a firstswitch for controlling the first surgical system, and providing a formercomprising a hand-shaped portion. The former can include a firstdepression for receiving the first surgical system, and the firstdepression can be adapted to produce an interference fit with at least aportion of the first surgical system. The first surgical system can beloaded into the first depression. A polymer coating can be applied overthe loaded former then cured and/or dried to form a surgical glove withthe surgical system integrated (e.g., partially or fully embedded)therein. The methods described herein can be used to make any of avariety of surgical gloves for use in the surgical systems describedherein or in the Schneider Patents.

The first depression can include a first surgical instrument receivingportion and a first switch receiving portion. The first surgical systemcan also include a first conduit, and the first depression can include afirst conduit receiving portion.

The interference fit can be formed with a portion of the first surgicalinstrument, a portion of the first switch, or both. The first surgicalsystem can also include a proximal interconnection and the interferencefit can be formed with a portion of one or more of the first surgicalinstrument, the first switch, and the proximal interconnection.

The former can include a wrist portion and a proximal forearm portion.The applying step can include dipping the loaded former into a pool ofcoating precursor. The method can also include removing the surgicalglove from the former by turning the surgical glove inside-out once thecoating precursor has stabilized, e.g., polymerized or cured,sufficiently to remove the glove without tearing. The coating precursorcan produce a polymer coating that is sufficiently elastic after it'sstabilized to enable the glove to be removed from the former withouttearing.

A portion of the first surgical system can be embedded within thesurgical glove and another portion of the first surgical system can beexposed. The exposed portion of the surgical instrument can include aportion of the first surgical instrument, a portion of the first switch,or a portion of both. The exposed portion can correspond to the portionof the first surgical system producing an interference fit with thefirst depression.

The method can also include providing a second surgical system thatincludes a second surgical instrument and a second switch forcontrolling the second surgical system. The former can also include asecond depression for receiving the second surgical system, and thesecond depression can be adapted to produce a second interference fitwith at least a portion of the second surgical system. The method canalso include loading the second surgical system into the seconddepression.

The first depression can include a first surgical instrument receivingportion and a first switch receiving portion, while the seconddepression can include a second surgical instrument receiving portionand a second switch receiving portion. The first and second surgicalsystems can include first and second conduits, respectively. The firstdepression can include a first surgical instrument receiving portion, afirst conduit receiving portion, and a first switch receiving portion,while the second depression can include a second surgical instrumentreceiving portion, a second conduit receiving portion, and a secondswitch receiving portion. The former can be designed so that the firstand second conduit receiving portions do not intersect.

An interference fit can be formed between the first depression and aportion of the first surgical instrument, a portion of the first switch,or both, and a second interference fit can be formed between the seconddepression and a portion of the second surgical instrument, a portion ofthe second switch, or both.

The first and second surgical systems can also include first and secondproximal interconnections, respectively. An interference fit can beformed with a portion of at least one of the first surgical instrument,the first switch and the first proximal interconnection, and a secondinterference fit can be formed with a portion of at least one of thesecond surgical instrument, the second switch and the second proximalinterconnection.

A portion of the first surgical system can be embedded within thesurgical glove and another portion of the first surgical system can beexposed. Similarly, a portion of the second surgical system can beembedded within the surgical glove and another portion of the secondsurgical system can be exposed. The exposed portion of the firstsurgical system can be a portion of the first surgical instrument, aportion of the first switch or both, and the exposed portion of thesecond surgical system can be a portion of the second surgicalinstrument, a portion of the second switch or both.

The former can also include a first discrete element depression. Thefirst depression can include a first surgical instrument receivingportion, and the first discrete element depression and the firstsurgical instrument receiving portion can overlap. For example, wherethe first surgical instrument receiving portion is adapted to receive anelectrocautery tip, the first discrete element depression can be adaptedto receive a heat shield, which can be separate from or coupled to theelectrocautery tip.

The method and former can be adapted for producing the surgical glovesystems as described herein and in the Schneider Patents. Exemplarysurgical gloves can include a first and second surgical system attachedto the surgical glove, where the first surgical system comprises a firstsurgical instrument and a first conduit and the second surgical systemcomprises a second surgical instrument and a second conduit. Each of thefirst and second surgical systems can be attached to an index finger, along finger, or a little finger of the surgical glove. A first switchcan be attached to the surgical glove for controlling the first surgicalsystem, and the first switch can be attached to a finger of the surgicalglove to which the first surgical system is attached. A second switchcan be attached to the surgical glove for controlling the secondsurgical system, and the second switch can be attached to a finger ofthe surgical glove to which the second surgical system is attached. Thefirst and second switches can be operable by a thumb of a human handwearing the surgical glove.

An advantage of this invention is that the method provides techniquesfor producing robust elastomeric gloves with surgical support systemsembedded partially or fully therein.

Another advantage of the invention is that the method providestechniques for producing robust elastomeric gloves with surgical supportsystems integrated therein, where the gloves are liquid and biologicallyimpermeable, safe for use in operating room conditions, and meetregulatory standards.

These and other embodiments are described in more detail below.

BRIEF DESCRIPTION OF THE DRAWINGS

The accompanying drawings, which are incorporated in and form a part ofthe specification, illustrate embodiments of the presently disclosedinvention and, together with the description, disclose the principles ofthe invention.

FIG. 1A is a volar view of a former for a surgical glove as describedherein; FIG. 1B is a volar view of the same former loaded with surgicalsystems, while FIG. 1C is a volar view of the same former loaded withboth surgical instruments and discrete elements.

FIG. 2A is a dorsal view, of the former of FIG. 1, and FIG. 2B is adorsal view of the same former loaded with surgical systems and discreteelements.

FIG. 3A is a side view of the former of FIG. 1, and FIG. 3B is a sideview of the same former loaded with surgical systems.

FIG. 4A is an end view of the former of FIG. 1, FIG. 4B is an end viewof the same former loaded with surgical systems, and FIG. 4C is an endview of the same former loaded with both surgical instruments anddiscrete elements.

FIG. 5A is a cross-sectional view of an interference fit with thecutting switch taken along outline 5A-5A of FIG. 3B, and FIG. 5B is across-sectional view of an interference fit with the suction controlport taken along outline 5B-5B of FIG. 3B.

FIG. 6 is a dorsal view of a surgical system as described herein,including a right-handed glove and a shunt coupled to a sleeve of asurgical gown.

FIG. 7 is a dorsal view of a surgical system as described herein,including a right-handed glove with a shunt coupled thereto.

FIG. 8 is a volar view of the surgical system shown in FIGS. 6 and 7.

FIG. 9A is a volar view of a former for making a polymeric glove withdiscrete elements as described herein, and FIG. 9B is a volar view ofthe same former loaded with discrete elements.

FIG. 10 is a volar view of a glove produced using the former of FIG. 9.

FIG. 11A is a volar view of a former for making a polymeric glove withdiscrete elements and component systems as, described herein, and FIG.11B is a volar view of the same former loaded with discrete elements andcomponent systems.

FIG. 12 is a volar view of a glove produced using the former of FIG. 11.

DETAILED DESCRIPTION OF THE INVENTION

A method of making polymeric gloves with component systems, discreteelements, or both, embedded therein is described. The method can be usedto completely or partially embed any of a variety of functionalcomponents (e.g., component systems, discrete elements) into a polymericglove. The method of making polymeric gloves can be used to produce awide variety of gloves including, but not limited to, surgical gloves,cleaning gloves, industrial gloves, and prophylactics. As used herein,“glove” is intended to have its conventional meaning and also includecondoms, which can be made using the techniques described herein.Similarly, “appendage-shaped” is intended to include both hand-shapedand phallus-shaped objects.

As shown in the Figures, a method of making a polymeric glove caninclude providing a first functional component. The first functionalcomponent can be selected from a first discrete element and a firstcomponent system coupled to a first conduit. The method can also includeproviding a former comprising an appendage-shaped portion, where theformer includes a first depression for receiving the first functionalcomponent. The method can include loading the first functional componentinto the first depression, and applying a polymer coating over theloaded former to form a polymeric glove. As described with respect tosurgical gloves below, depending on the desired properties andconfiguration, the applying step can occur after the loading step or theapplying step can occur both before and after the loading step.

As used herein, “functional component” is intended to include bothcomponent systems and discrete elements. As used herein, “componentsystems” include surgical and non-surgical functional components thatincludes a support conduit for physically connecting to a source (e.g.,power source, suction source, irrigation source, etc.) external to theglove. Exemplary component systems include, but are not limited to,light sources 16, cutting sources 18, suction/vacuum sources 20, 554,and irrigation sources 22.

As used herein, “discrete element” refers to a functional component thatdoes not include a conduit for physically connecting to a sourceexternal to the glove. Discrete elements must be adapted to functionallyenhance the glove and do not include fillers or debris embedded withinthe material forming the glove. A discrete element could benon-physically connected to an external source, such as via a wirelessconnection, and could include an internal battery as a power supply.Exemplary discrete elements include, but are not limited to, insulatingmaterials (e.g., heat shield), reinforcing elements, battery operatedlight sources, temperature strips, reflective elements, resistancethermometers, brushes and other cleaning implements, gripping andfriction enhancing elements, and detection strips (e.g., pH, bacteria,toxin, etc.).

The first depression can be adapted to produce an interference fit withat least a portion of a first functional component. A portion of thefirst functional component can be embedded within the polymeric gloveand another portion of the first functional component can be exposed.

The first functional component can be a first discrete element. Thefirst discrete element—and any other discrete element describedherein—can be a discrete element selected from the group consisting ofinsulating materials (e.g., heat shield), reinforcing elements, batteryoperated light sources, temperature strips, reflective elements,resistance thermometers, brushes and other cleaning implements, grippingand friction enhancing elements, and detection strips (e.g., pH,bacteria, toxin, etc.).

The first functional component can be a first component systemcomprising a first active end and a first conduit, and the firstdepression can include a first active end receiving portion and a firstconduit receiving portion. In such methods, the loading step can includeloading the first active end into the first active end receiving portionand the first conduit into the first conduit receiving portion.

The method can also include providing a second functional component. Thesecond functional component can be selected from a second discreteelement and a second component system coupled to a second conduit. Theformer can include a second depression for receiving a second functionalcomponent. The method can include loading the second functionalcomponent into the second depression. The first and second functioncomponents can be different or the same.

The method can be performed using at least two functional components, atleast three functional components, at least four functional components,at least five functional components or more. Any combination of discreteelements and component systems can be used in the method.

As shown in FIG. 9, the former 210 can be adapted for producing acleaning glove 512. FIG. 9A shows the former 210 in the unloaded state,while FIG. 9B shows the former 210 loaded with the discrete elements522, 526.

In such a method, the former 210 can include discrete element receivingportions 410 at the distal, volar portion of the thumb 412 and each ofthe fingers 414, 416, 418, 420. The discrete element receiving portions410 at the distal, volar portions of the thumb 412, index finger 414,long finger 416 and ring finger 418, respectively, can each be adaptedto receive scrubbing elements 522. Exemplary scrubbing elements 422include, but are not limited to brushes, raised surfaces, undulatingsurfaces, and nubbed surfaces. The scrubbing surface 524 of thescrubbing elements 522 may be embedded in or protruding from theresulting glove 510, shown in FIG. 10.

The discrete element receiving portion 420 at the distal, volar portionof the little finger can be adapted to receive a detecting element 526,such as, a bacteria tester. The detecting element can be used to testfor certain types of bacteria while the user is wearing the glove 512formed using the former 210. The detection surface 528 can be embeddedin or protruding from the glove 512 shown in FIG. 10. As will beunderstood, when it is desired for the discrete element 522, 526 to havean exposed surface (e.g., 524, 528), the discrete element receivingportions 410 can form an interference fit with the discrete element 522,526.

As shown in FIG. 10, the glove 512 can include scrubbing elements 522 atthe distal, volar portions of the thumb, index finger, long finger andring finger, and a detecting element 526 at the distal, volar portion ofthe little finger. In some gloves 512, for example when the scrubbingelements 522 are undulated surfaces, the scrubbing elements 522 can alsofacilitate gripping of objects. During the cleaning process, the usercan monitor the detecting element 526 to determine if any undesirablebacteria or toxins are present. The detecting element 526 can be adaptedto change appearance (e.g., color) if a target bacteria or toxin ispresent.

FIG. 11 shows a former 210 for producing the suction glove 552 shown inFIG. 12. The suction glove 552 can be adapted for handling delicateobjects without introducing oils from the hand. For example, the suctionglove 552 can be used to transport wafers or other objects in cleanrooms.

As shown in FIG. 12, the glove 552 can include component systemscomprising a vacuum cone 554 attached to distal, volar portions of theindex finger, long finger and ring finger of the glove. Each of thevacuum cones 554 can be coupled to vacuum conduits 556 that extend alonga radial aspect of the finger to which each vacuum cone 554 is attachedand then over onto the dorsal aspect of the metacarpal of that fingerbefore terminating at an interconnect in a manner analogous to thevacuum conduit 60 shown in FIG. 6. The vacuum conduits 4556 can becoupled to the vacuum cones 554 proximate an apex of the vacuum cones554. The vacuum conduit 556 can also extend along an ulnar aspect of thefinger to which it is attached in a manner analogous, but opposite, tothat shown in FIG. 12. The glove 552 can also include a gripping element530 on a volar surface of the thumb of the glove 552.

The inner surface 558 of the vacuum cone 554 can be protruding from theglove 552 and free from a coating of the polymer forming the body of theglove 552 (i.e., the inner surface 558 can be exposed). Similarly, thegripping surface 532 of the gripping element 530 can be exposed and/orprotruding from the glove 552. As will be understood, when it is desiredfor a portion of the functional components 554, 530 to have a exposedsurface (e.g., 532, 558) the corresponding receiving portions 412, 454can form an interference fit with the functional components 554, 530.

FIG. 11A shows the former 210 in the unloaded state, while FIG. 11Bshows the former 210 loaded with the vacuum systems 554, 556 and thegripping element 530. The vacuum cone receiving portions 454 are locatedat distal, volar portions of the index finger, long finger and ringfingers of the former 210. Vacuum conduit receiving portions 456 extendfrom the vacuum cone receiving portions 454 to a radial aspect of thefinger on which each vacuum cone receiving portion 454 is located andthen over onto a dorsal aspect of the metacarpal of that finger beforeterminating. The vacuum conduit receiving portion 456 can terminate inan interconnect receiving portion in a manner analogous to the suctionconduit receiving portion 260 as shown in FIG. 2A. The thumb of theformer 210 can also include a discrete element receiving portion 412,which can be loaded with a gripping element 530. The gripping element530 can be useful for separating the component (e.g., a silicon wafer)being handled using the glove from the vacuum cones 554.

As a specific application of the method of making polymeric gloves, amethod of making surgical gloves with surgical support systems embeddedtherein is also described. Although the following discussion is directedtoward surgical gloves, surgical support systems, and surgical discreteelements, it should be understood that the techniques described hereincan be used to embed any type of functional element into any polymericglove or similar device. It should also be noted that the phrases“support system” and “component system” are used interchangeably herein.

The method can include providing an hand-shaped former 210 with aplurality of depressions, as shown in FIGS. 1A, 2A, 3A & 4A, and loadingthe depressions with corresponding surgical systems. A coating can beformed over and around the surgical systems by dipping the loaded formerinto a coating precursor solution one or more times. The method caninclude dipping the former into more than one coating precursorsolution. The method can also include dipping the former into one ormore coating precursor solutions—and, optionally, allowing the coatingprecursor to cure—prior to loading the former.

Prior to describing the method in more detail, exemplary gloves that canbe made using the method will be described. The method described hereincan be used to produce the gloves described in U.S. Pat. Nos. 7,931,648,7,951,145 and 8,182,479 to Schneider, and U.S. patent application Ser.No. 13/626,733, entitled “Surgical Glove System, and Methods of Usingthe Same,” filed Sep. 25, 2012, the entirety of which is incorporatedherein by reference.

As shown in FIGS. 6-8, the surgical system 10 can include a surgicalglove 12 configured to be removably attached to a human hand. The glove12 can include first and second surgical systems 14 attached to theglove 12, wherein the first surgical system 14 comprises a firstsurgical instrument 17 and a first conduit 15, and the second surgicalsystem 14 comprises a second surgical instrument 17 and a second conduit15. Each of the first and second surgical systems 14 can be attached toan index finger, a long finger or a little finger of the surgical glove12. Similarly, as shown in the Figures, the thumb and the ring finger ofthe surgical glove 12 can be free of all surgical systems 14.

The surgical systems 14 can also include a first and a second switch(e.g., 48, 56, 58, 62, 64, 70 and 140) attached to the glove 12 forcontrolling the first and second surgical systems 14, respectively. Thefirst and second switches (e.g., 48, 56, 58, 62, 64, 70 and 140) can beattached to a finger of the glove 12 to which the first and secondsurgical systems 14 are attached, respectively. The first and secondswitches (e.g., 8, 56, 58, 62, 64, 70 and 140) can be operable by athumb of a human hand wearing the glove 12.

The surgical systems 14 can also include (i) a safety switch 140attached to the glove 12 for controlling the first surgical system 14 sothat said first surgical system 14 will not operate unless both saidfirst switch (e.g., 56 or 58) and the safety switch 140 are actuatedsimultaneously, or (ii) a shunt 142 for controlling fluid flow betweensaid first and second conduits (e.g., 60 and 68). In some cases, thesurgical system 14 can include one or more additional surgical systems14 and can include both a safety switch 140 and a shunt 142.

The surgical system 10 can also include a surgical gown 30 that includesa support system comprising first and second support conduits 34 forcoupling to the first and second conduits 15 of the surgical glove 12,respectively. The first and second support conduits 15 can be attachedto the first sleeve of the gown 30 and can terminate is supportconnectors 149.

The first and second surgical systems 14 can include at least oneirrigation port 22 and at least one suction port 20, respectively. Thesurgical system 10 can include a shunt 142 for controlling fluid flowbetween the irrigation conduit 68 and the suction conduit 60. The shunt142 can be used to direct the flow of fluid from the irrigation conduit68 to the suction conduit 60. The shunt 142 can also be used to directthe flow of fluid toward the suction port 22, away from the suction port22, or both, either simultaneously or alternately. This can beparticularly useful for clearing debris, such as tissue, from thesuction system (22, 68 & 69).

The shunt 142 can include first and second T-valves 144, 146 in fluidcommunication with the irrigation conduit 68 and the suction conduit 60,respectively. The first T-valve 144 can be in fluid communication withthe second T-valve 146. As shown in FIG. 6, a first portion of the shunt(e.g., 144) can be in-line with the irrigation support conduit 69 and asecond portion of the shunt (e.g., 146) can be in-line with the suctionsupport conduit 61. Alternately, as shown in FIG. 7, a first portion ofthe shunt (e.g., 144) can be in-line with the irrigation conduit 68 anda second portion of the shunt (e.g., 146) can be in-line with thesuction conduit 60.

As shown in FIGS. 6-8, the surgical glove 12 can include light sources16, an electrocautery device 18, a suction port 20, and an irrigationport 22 coupled to the same glove. A first light source 16 can belocated on a distal portion of an index finger and a light conduit 42can run along an ulnar portion of the index finger onto a dorsal portion150 of the metacarpals (e.g., between the second and third metacarpals).A second light source 16 can be located on a distal portion of a longfinger and a light conduit 42 can run along an ulnar portion of the longfinger onto a dorsal portion 150 of the metacarpals (e.g., between thethird and fourth metacarpals). The first and second light source controlswitches 48 can be attached to an ulnar portion of the finger of theglove to which the first and second light sources 16, respectively, areattached.

As shown in FIGS. 6-8, an electrocautery device 18 can be coupled to adistal or distal, volar 152 portion of the index finger. Theelectrocautery conduit 52 can run from the electrocautery device 18along a radial portion of the index finger and then onto a dorsalportion 150 of the metacarpals (e.g., along a radial-dorsal portion of asecond metacarpal). A cutting switch 56 and a coagulating switch 58 canbe coupled to the electrocautery conduit 52 and positioned along aradial surface of the index finger such that the cutting and coagulatingswitches 56, 58 can be actuated by a thumb of the hand wearing thesurgical glove 12. As used herein, “electrocautery device” is usedbroadly and is intended to include cutting sources such as electricalcautery sources, ultrasonic cutting surgical devices, and ultrasoniccoagulating surgical devices.

As shown in FIG. 8, a heat shield 80 can be coupled to the glove andpositioned between the user's hand and the electrocautery tip 18. Thispositioning can be adapted to prevent injury to the user and damage tothe glove. The heat shield 80 can be separate from, or coupled to, theelectrocautery tip 18.

As shown in FIG. 7, a safety switch 140 can be coupled to theelectrocautery conduit 52 and positioned such that none of the fingersof the hand wearing the surgical glove 12 can actuate the safety switch140. For example, the safety switch 140 can be positioned along a dorsalaspect 150 of the glove 12 covering the metacarpals of a hand wearingthe glove. As shown in FIG. 7, the safety switch 140 can be attached tothe surgical glove 12 proximate a dorso-radial aspect of a secondmetacarpal of a human hand wearing the surgical glove 12.

The electrocautery system can be designed such that the electrocauterydevice 18 cannot be activated unless both the safety switch 140 and theappropriate switch (56 or 58, respectively) are actuated simultaneously.Because of the positioning of the safety switch 140, activation of theelectrocautery device 18 requires two hands and the potential for injuryto the patient, the surgeon or other operating room personnel is greatlyreduced or eliminated.

As shown in FIGS. 6-8, a suction port 20 can be coupled to a distal ordistal, radial portion of the long finger. The suction conduit 60 canrun from the suction port 20 along a radial aspect of the long fingerand then onto a dorsal portion 150 of the metacarpals (e.g., along adorsal portion between the second and third metacarpals). A suction portcontrol switch 62 and a suction control port 64 can be provided alongthe suction conduit 60. The suction port control switch 62 and thesuction control port 64 can be positioned along a radial surface of thelong finger such that the suction port control switch 62 and the suctioncontrol port 64 can be actuated by a thumb of the hand to which thesurgical glove 12 is attached.

As shown in FIGS. 6-8, an irrigation port 22 can be coupled to a distalor distal, radial portion of the lithe finger. The irrigation conduit 68can run from the irrigation port 22 along a radial portion of the littlefinger and then onto a dorsal portion 150 of the metacarpals (e.g.,along a dorsal portion on the radial or ulnar side of the fifthmetacarpal). An irrigation control switch 70 can be provided along theirrigation conduit 68. The irrigation control switch 70 can bepositioned along a radial surface of the little finger such that theirrigation control switch 70 can be actuated by a thumb of the hand towhich the surgical glove 12 is attached.

Each of the conduits (42, 52, 60 and 68) can include a terminalinterconnect 148 as a proximal end of the conduit. As shown in FIGS. 6and 7, each of the terminal interconnects 148 can correspond to asupport interconnect 149 located as a distal end of a correspondingsupport conduit (43, 53, 61 and 69). As shown in FIG. 7, the conduits(42, 52, 60 and 68) can terminate in a combined terminal interconnect148 and the support conduits (43, 53, 61 and 69) can terminate in acombined support interconnect 149. The terminal interconnect(s) 148 canbe a male or female interconnect and the support interconnect(s) 149 canbe a complementary female or male interconnect.

Each of the conduits (42, 52, 60 and 68) can traverse a mid-coronalplane of a finger of the surgical glove 12. Similarly, each of theconduits (42, 52, 60 and 68) can follow a linear isometric path along afinger of the glove. This is of great benefit as it allows themanufacture of a snug fitting surgical glove with the conduits embeddedtherein. If, as in the prior art, the conduits are positioned alongvolar or dorsal surfaces of the glove, it is not possible to obtain thedesired fit without increasing the risk of separation of the conduitfrom the glove.

Although FIGS. 6-8 are depicted with respect to a right-handed glove, itshould be understood that any of the descriptions provided herein canapply equally to the left hand. To facilitate the description ofleft-handed gloves, the positioning of all aspects of the surgicalsystem have been provided such that they are spatially unambiguousregardless of whether they refer to a right-handed glove or aleft-handed glove. Of course, any and all of the surgical systemsdescribed herein can be attached to a right-handed glove or aleft-handed glove. In some instances, the surgical system can includeboth a right-handed glove and a left-handed glove.

As shown in FIGS. 6-8, the surgical glove can also include additionaldiscrete elements. The additional discrete elements can be embedded inthe surgical glove. As will be understood, discrete elements generallyrefer to devices or objects attached to (embedded in) the surgical glovethat do not include a conduit terminating in a terminal interconnect 148(e.g., does not require a support conduit). Exemplary, discrete elementsinclude, but are not limited to, a heat shield, a reinforcing element, abattery operated light source, a temperature strip, a reflectiveelement, and a resistance thermometer.

FIGS. 6-8 show reinforcing elements 82 and 86 on the distal volar anddistal dorsal portions of the thumb, respectively. The reinforcingelements (e.g., a mesh) can be designed to prevent tears to the glovewhen the thumb actuates the various switches (e.g., 48, 65, 58, 62, 64and 70) or is used to manipulate or grasp other instruments.

In addition, discrete element 84 is positioned on a distal, volarportion of the long finger. This discrete element 84 can provide areinforcing function or can provide an independent function, such asbeing a resistance thermometer, a reflector, or a temperature strip.

Reflective elements 88, 90 can be positioned proximate the light sources16. As shown in FIGS. 6.8, the reflective elements 88, 90 can bepositioned at distal ends of the index and long fingers, respectively.The reflective elements 88, 90 can be adapted for directing lightemitted from the light sources 16 in a volar, distal direction. Thisenables the user to better illuminate the target, e.g., surgical field.Each reflective element 88, 90 can be separate from or coupled to thelight source 16. The reflective elements 88, 90 can also be produced ofa material adapted to insulate the user's hand and/or the glove from theheat radiating from the lights source 16 (e.g., halogen light).

It should be noted that, because the discrete elements (e.g., 80, 82,84, 86, 88 & 90) can be thin, uniform sheets, the discrete elements canbe included on any portion of the hand or any of the fingers, includingthe thumb and/or ring finger, without interfering with the surgeon'sability to manipulate surgical clamps or other surgical devices whilewearing the surgical gloves. Alternately, the thumb and/or ring fingerof the gloves can be free of both surgical systems and discreteelements.

Having described exemplary surgical gloves that can be made using themethod described herein, a method of making surgical gloves such asthose shown in FIGS. 6-8 is disclosed. The method can include providingan hand-shaped former 210 with a plurality of depressions and loadingthe depressions with corresponding surgical systems. A coating can beformed over and around the surgical systems by dipping the loaded formerinto a coating precursor solution one or more times. The method caninclude dipping the former in to more than one coating precursorsolution FIGS. 1-4 show exemplary formers 210 both with and withoutsurgical systems 14.

As used herein, “depression” refers to an indentation for receiving aportion of a surgical system. Depressions—especially those for surgicalsystems—can include channel portions with generally U-shaped or V-shapedcross-sections having opposing sides that are generally parallel to oneanother. As used herein, “generally” refers to the general appearance ofa cross-section or a minor deviation for a referenced orientation. Forexample, generally parallel sides deviate from parallel by ≦30°, or≦20°, or ≦10°, or ≦5°. The sides of the depressions 214 described hereincan have generally parallel sides where they are designed to form aninterference fit with a portion of a surgical system 14. This helpsenable the opposing sides of the former to for a liquid tight seal withthe sides of the portion of the surgical system 14. It should beobserved that where the cross-section is taken through the center of adepression that is circular, elliptical or similarly shaped, the sidesof that shape can be considered generally parallel.

The method can include providing a first surgical system 14 comprising afirst surgical instrument 17 and a first switch (e.g., 48, 56, 58, 62,64, 70 & 140) for controlling the first surgical system 14. The methodcan include providing a former 210 comprising an hand-shaped portion212. The former 210 can include a first depression 214 for receiving thefirst surgical system 14. The first depression 214 can be adapted toproduce an interference fit with at least a portion of the firstsurgical system 14. The first surgical system 14 can be loaded into thefirst depression 214 and a polymer coating can be applied over theloaded former 210 to form a surgical glove 12. In addition to thehand-shaped portion, the former 210 can include a wrist portion and aproximal forearm portion.

The method can also include providing at least one discrete element(e.g., 80, 82, 84, 88) such as, but not limited to, a heat shield, areinforcing material and a temperature indicating device. The former 210can include at least one discrete element depression (e.g., 280, 282,284, 288, 290) for receiving the at least one discrete element (e.g.,80, 82, 84, 86, 88, 90). The at least one discrete element depression(e.g., 280, 282, 284, 286, 288, 290) can be, but is not necessarily,adapted to produce an interference fit with at least a portion of thediscrete element (e.g., 80, 82, 84, 86, 88, 90). The at least onediscrete element can be loaded into the at least one discrete elementdepression (e.g., 280, 282, 284, 286, 288, 290) and a polymer coatingcan be applied over the loaded former 210 to form a surgical glove 12using the methods described herein.

The applying step can include dipping the loaded former 210 into a poolof coating precursor. The applying step can include dipping the loadedformer 210 into a pool of coating precursor more than once. The applyingstep can include dipping the loaded former 210 into more than one poolof coating precursor. For example, the loaded former 210 can be dippedinto a polymer precursor and then into a polymer stabilization pool(e.g., cross-linker, catalyst, initiator, etc.). The method can becontinuous. The method can include heating the loaded former 210 priorto dipping in order to facilitate formation of a coating on the loadedformer 210.

As used herein, “coating precursor” is intended to include a compositionhelpful for forming a stabilized coating. Exemplary coating precursorsinclude, but are not limited to, polymer precursors (e.g., monomersolutions), polymer solutions (e.g., latex solutions), catalysts,initiators, cross-linkers and mixtures thereof.

As used herein, “interference fit” is intended to refer to a seal thatis fluid tight with respect to the coating precursor. In other words,former-side portions of features of a surgical system that form aninterference fit with the former 210 will not be coated during theforming process and will be exposed (i.e., uncoated) once the glove 12is removed from the former 210. In contrast, because the loaded former210 is dipped in the coating precursor, all other portions of thesurgical system 14 will be surrounded by (i.e., embedded within) theglove material.

The first depression 214 can include a first surgical instrumentreceiving portion 217 and a first switch receiving portion (e.g., 248,256, 258, 262, 264 & 270). The first surgical system 14 can also includea first conduit 15 and the first depression 214 can also include a firstconduit receiving portion 215. The first surgical system 14 can alsoinclude a proximal interconnection 148 and the first depression 214 canalso include a proximal interconnection receiving portion 348. Theinterference fit can be formed with a portion of the first surgicalinstrument 17, a portion of the first switch (e.g., 48, 56, 58, 62, 64,70 & 140), a portion of the proximal interconnection 148, or acombination thereof. In some formers 210, there will not be aninterference fit between the conduit 15 and the first conduit receivingportion 215.

The method can also include removing the surgical glove 12 from theformer 210 by turning the surgical glove 12 inside-out. A portion of thefirst surgical system 14 can be embedded within the surgical glove 12and a portion of the first surgical system 14 can be exposed (i.e.,extend from the surgical glove 12). The exposed portion can include aportion of the first surgical instrument, a portion of the first switch,or both. The exposed portion can correspond to the former-side of theportion of the first surgical system 14 producing an interference fitwith the first depression 214.

As will be understood, it may be particularly useful to have particularportions of the surgical system 14 exposed. Portions that can bebeneficial to expose include, but are not limited to, surgicalinstruments 17, switches (e.g., 48, 56, 58, 62, 64, 70 & 140), ports,and terminal interconnections 148. This may be particularly useful forproviding access to switches and ports, as well as, for embodimentswhere the surgical instruments are removable. In such embodiments, theremovable portion cab be attached to the glove after the formingprocess. In some methods, the former 210 may be dipped, fingers first,into the coating precursor pool to a depth such that the terminalinterconnections do not contact the pool of coating precursor.

The method can also include providing a second surgical system 14comprising a second surgical instrument 17 and a second switch (e.g.,48, 56, 58, 62, 64, 70 & 140) for controlling the second surgical system14. The former 210 can also include a second depression 214 forreceiving the second surgical system 14. The second depression 214 canbe adapted to produce an interference fit with at least a portion of thesecond surgical system 14. The second surgical system 14 can be loadedinto the second depression 214.

The second depression 214 can include a second surgical instrumentreceiving portion 217 and a second switch receiving portion 215. Thesecond surgical system 14 can also include a second conduit 15 and thesecond depression 214 can include a second conduit receiving portion215. The second surgical system 14 can also include a proximalinterconnection 148 and the second depression 214 can include a proximalinterconnection receiving portion 348. The interference fit can beformed with a portion of the second surgical instrument 17, a portion ofthe second switch (e.g., 48, 56, 58, 62, 64, 70 & 140), a portion of theproximal interconnection 148, or a combination thereof. In some formers210, there will not be an interference fit between the second conduit 15and the second conduit receiving portion 215.

As will be understood, additional surgical systems 14 and depressions214 can be included in order to produce any and all embodiments ofsurgical gloves 12 described herein. For example, the depressions 214for receiving the surgical systems 14 can be positioned in an indexfinger, a long finger or a lithe finger of the former 210. Similarly, asshown in FIGS. 1-4, the thumb and the ring finger of the former 210 canbe free of all depressions for receiving surgical systems 214. In someformers 210, the multiple depressions 214 do not intersect with oneanother in order to facilitate uniform coating of the surgical systems214.

Depending of the desired configuration, the some or all of the surgicalsystems 14 and discrete elements (e.g., 80, 82, 84, 86, 88, 90) can beloaded into the respective depressions 214 before or after the former210 is dipped into the first coating precursor material. Where thesurgical system(s) 14 and/or discrete elements (e.g., 80, 82, 84, 86,88, 90) are loaded into the respective depressions after the former 210is dipped into the coating precursor material, the former 210 willgenerally also be dipped into the coating precursor material after thesurgical systems 14 and/or discrete elements (e.g., 80, 82, 84, 86, 88,90) are loaded into the former 210.

When the surgical system(s) 14 and/or discrete elements (e.g., 80, 82,84, 86, 89, 90) are intended to be completely embedded in the glove, themethod may be performed so that the former 210 is dipped both before andafter the surgical system(s) 14 is/are loaded into the depressions 214of the former 210. In such methods, the former 210 may be dipped morethan once before the surgical system(s) 14 is/are loaded 210 and morethan once after the surgical system(s) 14 is/are loaded into the former210. For example, they former may be dipped into a polymer precursor(e.g., monomer solutions) or polymer solution (e.g., latex solutions)and subsequently dipped into a solution containing one or more of acatalyst, an initiators and a cross-linker.

FIGS. 1-4 depict a former 210 that can be used to make a glove that isthe mirror image of the glove shown in FIG. 6. In FIGS. 1-4, the Aseries (FIGS. 1A, 2A, 3A & 4A) shows various perspectives of the former210 and the empty depressions 214 therein, while the B series (FIGS. 1B,2B, 3B & 4B) shows those same perspectives of the former 210 where thedepressions 214 are loaded with the surgical systems 14 and, in the caseof 2B, discrete elements. FIGS. 1C and 4C show the volar perspective ofthe former 210 loaded with both surgical systems 14 and discreteelements.

FIGS. 1-4 show various views of a former 210 used to form a left-handedglove. The former 210 can include a suction system depression 360. Asshown in the volar view of FIG. 1, the suction system depression 360 caninclude a suction device receiving portion 220, a suction port controlswitch receiving portion 262, a suction control port receiving portion264, and a suction conduit receiving portion 260. As shown in FIG. 2,the suction system depression 360 can include a terminal connectorreceiving portion 348 proximate a wrist portion of the former 210. Thesuction system depression 360 can start proximate a distal end of thelong finger and extend along volar aspects, radial aspects orvolar-radial aspects of the long finger. As shown in FIG. 2, the suctionsystem depression 360 can then continue to a dorsal side of the former210 between the long finger and the index finger of the former andextend between or proximate the second and third metacarpals.

An exemplary interference fit for the suction control port 64 is shownin FIG. 5B. The suction control port 64 can be an opening in the suctionconduit 60. As shown in FIG. 5B, suction control port receiving portion264 can include a suction control port projection 364 adapted forplugging the suction control port 64. The fit between the sides of thesuction control port 64 and the suction control port projection 364 canbe sufficient to prevent coating precursor from flowing between thesides and into the lumen 464 of the suction conduit 60.

The former 210 can also include an irrigation system depression 362. Asshown in the volar view of FIG. 1, the irrigation system depression 362can include an irrigation device receiving portion 222, an irrigationcontrol switch receiving portion 270, and an irrigation conduitreceiving portion 268. As shown in the dorsal view of FIGS. 2A and 2B,the irrigation system depression 362 can include a terminal connectorreceiving portion 348 proximate a wrist portion of the former 210. Theirrigation system depression 362 can start proximate a distal end of thelittle finger and extend along volar aspects, radial aspects orvolar-radial aspects of the little finger. As shown in FIG. 2, theirrigation system depression 362 can then continue to a dorsal side ofthe former 210 between the ring finger and the little finger of theformer and extend between or proximate the fourth and fifth metacarpals(e.g., along an ulnar portion of the fourth or fifth metacarpal).

The former 210 can also include a cutting system depression 364. Asshown in the volar view of FIG. 1, the cutting system depression 364 caninclude a cutting device receiving portion 218, a cutting switchreceiving portion 256, a coagulation switch receiving portion 258, and acutting conduit receiving portion 252. As shown in the dorsal view ofFIG. 2, the cutting system depression 364 can include a terminalconnector receiving portion 348 proximate a wrist portion of the former210. The cutting system depression 364 can start proximate a volaraspect of the distal end of the index finger and extend along radialaspects of the index finger. As shown in FIG. 2, the cutting systemdepression 364 can then continue to a dorsal side of the former 210between the thumb and index finger of the former and extend between orproximate the first and second metacarpals (e.g., along a radial portionof the second metacarpal).

An exemplary interference fit is shown in FIG. 5A, which shows across-section of the relative positioning of the cutting switch 56 andcutting switch receiving portion 256, where the cutting switch 56 is adepression actuated switch. The cutting switch 56 can include a base 156and a switch (e.g., button) 157 extending from the base 156, where thebase 156 is wider than the switch 157. Similarly, the cutting switchreceiving portion 256 can be tiered to include a base receiving portion356 and a switch receiving portion 357 that extends deeper into theformer 210 than the base receiving portion 356. The width of the basereceiving portion 356 can be greater than the base 156 so that thecoating precursor material can flow between the base 156 and the basereceiving portion 356 when the former 210 is dipped into the coatingprecursor. However, the width of the switch receiving portion 357 andthe switch 157 can be substantially identical so that there is contactbetween the sides of the switch 157 and the switch receiving portion 357sufficient to prevent the coating precursor from flowing between thesides, i.e., sufficient to form an interference fit. The depth of theswitch receiving portion 357 relative to the switch 157 can be selectedto allow coating precursor to flow between lateral faces 158, 258 of thebase 156 and base receiving portion 256, as shown in FIG. 5A, or to forman interference fit between the lateral faces 158, 258. Of course, thisinterference fit configuration can apply to any of theswitches—especially depression actuated switches—described herein (e.g.,48, 56, 58, 62, 64, 70) or envisioned for use with the methods andsystems described herein.

The former 210 can also include one or more light source systemdepressions 366, 368. As shown in the dorsal view of FIG. 2, the lightsource system depressions 366, 368 can include light source receivingportions 216, light source switch receiving portions 248, and a lightsource conduit receiving portions 242. As shown in the dorsal view ofFIG. 2, the light source system depressions 364 can include a terminalconnector receiving portion 348 proximate a wrist portion of the former210.

The first light source system depression 366 can start proximate adistal end of a dorsal or distal aspect of the long finger and extend toan ulnar aspects of the long finger. As shown in FIG. 2, the first lightsource system depression 366 can then continue to a dorsal side of theformer 210 between the long finger and ring finger of the former andextend between or proximate the third and fourth metacarpals (e.g.,along an ulnar portion of the third metacarpal).

Similarly, the second light source system depression 368 can startproximate a distal end of a dorsal or distal aspect of the index fingerand extend to an ulnar aspects of the index finger. As shown in FIG. 2,the first light source system depression 368 can then continue to adorsal side of the former 210 between the index finger and long fingerof the former and extend between or proximate the second and thirdmetacarpals (e.g., along an ulnar portion of the second metacarpal).

The former 210 can also include one or more discrete element depressions(e.g., 280, 282, 284, 286, 288, 290). As shown in the volar view of FIG.1, a heat shield depression 280 can be positioned at a distal end of anindex finger of the former 210. The heat shield depression 280 canoverlap with a portion of the cutting device receiving portion 218 ofthe cutting system depression 364. The heat shield depression 280 can begenerally rectangular or any other appropriate shape for use inconnection with the cutting device. The cutting device receiving portion218 will generally extend deeper than the heat shield depression 280 sothat the cutting device 18 can be loaded, as shown in FIG. 1B, and thencovered by the heat shield 80, as shown in FIG. 1C. Alternately, theheat shield 80 and cutting device 18 can be a single element. In orderto simplify the Figures, discrete element depressions 280, 282 and 284are only shown in FIG. 1.

The former 210 can include at least one reinforcing element depression282, 286. As shown in FIG. 1, a reinforcing element depression 282 canbe positioned at a distal end of a volar aspect of the thumb of theformer 210. As shown in FIG. 2, a reinforcing element depression 286 canbe positioned at a distal end of a dorsal aspect of the thumb of theformer 210. These locations of the thumb may be reinforced in order toreduce wear when these locations are used to actuate switches embeddedin, or protruding from, the glove. As will be understood, reinforcingelements can be positioned on any portion of the former 210 where itwould be desired to reinforce the glove, including any aspect of thefingers and the volar or dorsal metatarsal region of the hand. Thereinforcing element depression(s) can be generally rectangular or anyother appropriate shape corresponding to the area where reinforcement indesired. In order to simplify the Figures, reinforcing elements 282, 286are only shown in FIGS. 1 and 2, respectively.

The former 210 can include additional discrete element depressions, suchas a thermometer strip depression 284. The corresponding thermometerstrip can visually indicate temperature for example by color. As shownin FIG. 1, a thermometer strip depression 284 can be positioned at adistal end of a volar aspect of the long finger of the former 210. Thethermometer strip depression 284 can be generally rectangular or anyother appropriate shape corresponding to the area where reinforcement indesired. In order to simplify the Figures, thermometer strip depression284 is only shown in FIG. 1.

As shown in the end view of FIG. 4, at least one reflective elementdepression 288, 290 can be positioned proximate light source receivingportions 216. As shown in FIG. 4, a first reflective element depressions288 can be positioned at a distal end of the index finger and a secondreflective element depressions 290 can be positioned as a distal end ofthe long finger. The reflective element depressions 288, 290 can overlapwith a portion of the light source receiving portions 216. Thereflective element depressions 288, 290 can be any shape helpful fordirecting light emitted from the light sources in a volar-distaldirection. The light source receiving portion(s) 216 will generallyextend deeper than the corresponding reflective element depression(s)288, 290 so that the light source 16 can be loaded, as shown in FIG. 4B,and then covered by the reflective element 88, 90, as shown in FIG. 4C.Alternately, the reflective element 88 or 90 and light source 16 can bea single element. In order to simplify the Figures, reflective elementdepressions 288, 290 are only shown in FIG. 4.

The depths and fit of the depressions can be varied in order to leaveappropriate portions of the surgical systems 14 exposed afterapplication of the coating and other portions completely embedded in theglove. For example, a loose fit may be desired around the conduits sothat they are completely embedded in the polymer forming the glove 12.In contrast, an interference fit between portions of a depression andportions of a surgical system may be utilized in order to have certainportions exposed, e.g., switches, ports and interconnects.

In some methods, the former 210 may be dipped only up to the wrist inorder to ensure that the proximal portions of the conduits (e.g., 42,52, 60 and 68) and the terminal connector 148 are exposed. For example,as shown in FIG. 2A, the former 210 may be dipped fingers first up tothe wrist (line D) into a pool of coating precursor. Thus, the proximalportions of a conduit and the terminal connector 148 would be exposed.Alternately, the method could include removing portions of the glove inorder to ensure that specific portions of the surgical systems 14 areexposed.

It is known to use formers in the production of elastomeric gloves.These conventional formers are shaped similarly to the human hand and donot include depressions, especially depressions adapted to receivesurgical systems and discrete elements such as those described herein.Thus, attachment of surgical systems to conventional elastomeric gloveswould require post-formation attachment of the surgical system to theelastomeric gloves, which is inefficient and risks the integrity of thebarrier function of the gloves. The claimed method and formers are asignificant improvement over the conventional techniques. Accordingly,the invention is also drawn to the formers described herein for use inthe methods described herein.

The foregoing is provided for purposes of illustrating, explaining, anddescribing embodiments of this invention. Modifications and adaptationsto these embodiments will be apparent to those skilled in the art andmay be made without departing from the scope or spirit of thisinvention.

I claim:
 1. A method of making a surgical glove, comprising: providing afirst surgical system comprising a first surgical instrument, and afirst switch for controlling the first surgical system; providing aformer comprising a hand-shaped portion, the former comprising a firstdepression for receiving the first surgical system; loading the firstsurgical system into the first depression to produce a loaded former;and applying a polymer coating over the hand-shaped portion of theloaded former to form a surgical glove, wherein at least a portion ofthe first surgical system is embedded within the surgical glove.
 2. Themethod according to claim 1, wherein the first depression is adapted toproduce an interference fit with at least a portion of the firstsurgical system.
 3. The method according to claim 2, wherein saidinterference fit is formed with a portion of one or more of said firstsurgical instrument, said first switch and said proximalinterconnection.
 4. The method according to claim 1, wherein saidapplying step comprises dipping said loaded former into a pool ofcoating precursor.
 5. The method according to claim 1, wherein saidfirst depression comprises a first surgical instrument receiving portionand a first switch receiving portion.
 6. The method according to claim1, wherein said first surgical system further comprises a first conduit.7. The method according to claim 6, wherein said first depressioncomprises a first surgical instrument receiving portion, a first conduitreceiving portion, and a first switch receiving portion.
 8. The methodaccording to claim 1, wherein the interference fit is formed with aportion of said first surgical instrument, a portion of said firstswitch, or both.
 9. The method according to claim 1, wherein said firstsurgical system further comprises a proximal interconnection.
 10. Themethod according to claim 1, further comprising removing the surgicalglove from the former by turning the surgical glove inside-out.
 11. Themethod according to claim 1, wherein a portion of said first surgicalsystem is embedded within the surgical glove and another portion of saidfirst surgical system is exposed.
 12. The method according to claim 11,wherein the exposed portion comprises a portion of said first surgicalinstrument, a portion of said first switch, or both.
 13. The methodaccording to claim 11, wherein the exposed portion corresponds to theportion of the first surgical system producing an interference fit withthe first depression.
 14. The method according to claim 1, furthercomprising: providing a second surgical system comprising a secondsurgical instrument and a second switch for controlling the secondsurgical system, wherein said former further comprises a seconddepression for receiving said second surgical system, and said seconddepression is adapted to produce a second interference fit with at leasta portion of the second surgical system; and loading said secondsurgical system into said second depression.
 15. The method according toclaim 14, wherein the first depression comprises a first surgicalinstrument receiving portion and a first switch receiving portion, andthe second depression comprises a second surgical instrument receivingportion and a second switch receiving portion.
 16. The method accordingto claim 14, wherein the first surgical system further comprises a firstconduit, and the second surgical system further comprises a secondconduit.
 17. The method according to claim 16, wherein the firstdepression comprises a first surgical instrument receiving portion, afirst conduit receiving portion, and a first switch receiving portion,and the second depression comprises a second surgical instrumentreceiving portion, a second conduit receiving portion, and a secondswitch receiving portion.
 18. The method according to claim 16, whereinthe first and second conduit receiving portions do not intersect. 19.The method according to claim 14, wherein an interference fit is formedwith a portion of said first surgical instrument, a portion of saidfirst switch, or both, and a second interference fit is formed with aportion of said second surgical instrument, a portion of said secondswitch, or both.
 20. The method according to claim 14, wherein the firstand second surgical systems further comprise first and second proximalinterconnections, respectively.
 21. The method according to claim 20,wherein an interference fit is formed with a portion of at least one ofsaid first surgical instrument, said first switch and said firstproximal interconnection, and a second interference fit is formed with aportion of at least one of said second surgical instrument, said secondswitch and said second proximal interconnection.
 22. The methodaccording to claim 14, wherein a portion of said first surgical systemis embedded within the surgical glove and another portion of said firstsurgical system is exposed, and wherein a portion of said secondsurgical system is embedded within the surgical glove and anotherportion of said second surgical system is exposed.
 23. The methodaccording to claim 22, wherein the exposed portion of said firstsurgical system comprises a portion of said first surgical instrument, aportion of said first switch or both, and the exposed portion of saidsecond surgical system comprises a portion of said second surgicalinstrument, a portion of said second switch or both.
 24. The methodaccording to claim 1, wherein the surgical glove comprises: a first andsecond surgical system attached to the surgical glove, wherein the firstsurgical system comprises a first surgical instrument and a firstconduit, wherein the second surgical system comprises a second surgicalinstrument and a second conduit, wherein each of the first and secondsurgical systems are attached to an index finger, a long finger or alittle finger of the surgical glove; a first switch attached to thesurgical glove for controlling the first surgical system, said firstswitch attached to a finger of the surgical glove to which the firstsurgical system is attached; a second switch attached to the surgicalglove for controlling the second surgical system, said second switchattached to a finger of the surgical glove to which the second surgicalsystem is attached, and wherein the first and second switches areoperable by a thumb of a human hand wearing the surgical glove.
 25. Themethod according to claim 1, wherein the former further comprises afirst discrete element depression.
 26. The method according to claim 25,wherein the first depression comprises a first surgical instrumentreceiving portion, and the first discrete element depression and thefirst surgical instrument receiving portion overlap.
 27. A method ofmaking a polymeric glove, comprising: providing a first functionalcomponent, wherein said first functional component is selected from afirst discrete element and a first component system coupled to a firstconduit; providing a former comprising an appendage-shaped portion, theformer comprising a first depression for receiving the first functionalcomponent; loading the first functional component into the firstdepression to produce a loaded former; and applying a polymer coatingover the appendage-shaped portion of the loaded former to form anpolymeric glove, wherein at least a portion of the first functionalcomponent is embedded within the polymeric glove.
 28. The methodaccording to claim 27, wherein said first depression is adapted toproduce an interference fit with at least a portion of said firstfunctional component.
 29. The method according to claim 28, wherein aportion of the first functional component is embedded within thepolymeric glove and another portion of the first functional component isexposed.
 30. The method according to claim 27, wherein: said firstfunctional component is a first component system comprising a firstactive end and a first conduit; said first depression comprises a firstactive end receiving portion and a first conduit receiving portion; andsaid loading step comprises loading said first active end into saidfirst active end receiving portion and said first conduit into saidfirst conduit receiving portion.
 31. The method according to claim 27,wherein said first functional component is a first discrete element. 32.The method according to claim 27, further comprising: providing a secondfunctional component, wherein said second functional component isselected from a second discrete element and a second component systemcoupled to a second conduit, wherein said former further comprises asecond depression for receiving a second functional component; andloading the second functional component into the second depression. 33.The method according to claim 27, wherein said first functionalcomponent is a first discrete element, and the first discrete element isembedded in a distal portion of a thumb of the glove.
 34. A method ofmaking a polymeric glove, comprising: providing a first functionalcomponent, wherein said first functional component is selected from afirst discrete element and a first component system coupled to a firstconduit; providing a former comprising an appendage-shaped portion;applying a first polymer coating over the appendage-shaped portion ofthe former to form a first glove layer; loading the first functionalcomponent over the first glove layer to produce a loaded former; andapplying a second polymer coating over the appendage-shaped portion ofthe loaded former to form a second glove layer, wherein the first andsecond glove layers form a polymeric glove, and wherein at least aportion of the first functional component is embedded within thepolymeric glove.